'On Your Feet to Earn Your Seat': update to randomised controlled trial protocol.
'On Your Feet to Earn Your Seat': update to randomised controlled trial protocol.
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DOI：
10.1186/s13063-015-0868-x
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发表时间：
2015-08-05
期刊：
影响因子：
2.5
通讯作者：
Hamer M
中科院分区：
文献类型：
--
作者：
Gardner B;Smith L;Aggio D;Iliffe S;Fox KR;Jefferis BJ;Hamer M
本次更新描述了我们的随机对照试验“On Your Feet to Earn Your Seat”程序的变化，这是一种基于习惯的干预措施，旨在减少老年人的久坐行为。一些修正案是由于增加了新的研究地点而产生的，每一个地点都为研究程序提供了不同的可能性和限制。其他研究是针对我们原始方案中描述的在伦敦研究中心实施预期招募程序时遇到的问题而进行的。所有变更均已获得伦理和监管部门的批准，并在数据收集之前或期间以及分析之前进行。研究中增加了5家非伦敦英国NHS研究中心（3家全科诊所、1家医院、1家NHS基金会信托），每家研究中心均采用了伦敦研究中心遵循的当地定制的招募和数据收集程序。与伦敦站点相比，新站点不收集加速度计数据，也不向参与者提供购物券。由于在联系参与者方面存在技术困难，伦敦研究中心的数据收集工作被推迟。随后，在伦敦研究中心（n = 23）实现了低于目标的样本量，招募率无法估计。此外，身体活动不足的纳入标准（即，<30分钟的连续休闲时间活动）已从所有研究中心中删除，因为我们发现伦敦研究中心的参与者在同意时满足这一标准，随后在基线评估时报告了高于这一阈值的活动。这主要是一个可行性试验。增加新的研究中心，每个研究中心采用不同的研究程序，提供了评估替代招募和数据收集方法可行性的机会，从而丰富了我们对主要结局分析的信息价值。招募已完成，伦敦研究中心的小样本与新研究中心的增加相吻合，确保了最终样本量与我们的原始目标相似。当前对照试验ISRCTN47901994（注册日期：2014年1月16日）
This update describes changes to procedures for our randomised controlled trial of ‘On Your Feet to Earn Your Seat’, a habit-based intervention to reduce sedentary behaviour in older adults. Some of the amendments have arisen from the addition of new sites, each offering different possibilities and constraints for study procedures. Others have been made in response to problems encountered in administering intended recruitment procedures at the London sites described in our original protocol. All changes have received ethics and governance clearance, and were made before or during data collection and prior to analyses. Five non-London UK NHS-based sites (three general practices, one hospital, one NHS Foundation Trust) have been added to the study, each employing locally-tailored variations of recruitment and data collection procedures followed at the London sites. In contrast to the London sites, accelerometry data are not being collected nor are shopping vouchers being given to participants at the new sites. Data collection was delayed at the London sites because of technical difficulties in contacting participants. Subsequently, a below-target sample size was achieved at the London sites (n = 23), and recruitment rates cannot be estimated. Additionally, the physical inactivity inclusion criterion (i.e., <30 consecutive minutes of leisure time activity) has been removed from all sites, because we found that participants at the London sites meeting this criterion at consent subsequently reported activity above this threshold at the baseline assessment. This is primarily a feasibility trial. The addition of new sites, each employing different study procedures, offers the opportunity to assess the feasibility of alternative recruitment and data collection methods, so enriching the informational value of our analyses of primary outcomes. Recruitment has finished, and the coincidence of a small sample at the London sites with addition of new sites has ensured a final sample size similar to our original target. Current Controlled Trials ISRCTN47901994 (registration date: 16th January 2014)